The decision is based on data from the phase III ECHELON-1 trial, in which brentuximab vedotin plus AVD compared with standard ABVD, which is defined as AVD plus bleomycin, demonstrated superior progression-free survival. In the trial, the brentuximab vedotin regimen was associated with a 23% reduction in the risk of progression, death, or initiation of new therapy versus ABVD.

The FDA granted a breakthrough therapy designation for brentuximab vedotin in combination with chemotherapy for frontline advanced classical Hodgkin lymphoma in October 2017.

The decision is based on data from the phase III ECHELON-1 trial, in which brentuximab vedotin plus AVD compared with standard ABVD, which is defined as AVD plus bleomycin, demonstrated superior progression-free survival. In the trial, the brentuximab vedotin regimen was associated with a 23% reduction in the risk of progression, death, or initiation of new therapy versus ABVD.

The FDA granted a breakthrough therapy designation for brentuximab vedotin in combination with chemotherapy for frontline advanced classical Hodgkin lymphoma in October 2017.